A Self-directed Positive Psychology Intervention for Individuals With Newly Diagnosed Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage of PP exercises completed by subjects
研究概览
简要总结
The goal of this clinical trial is to learn whether positive psychology (PP) exercises such as writing a letter of gratitude or remembering a past success can help individuals with newly diagnosed multiple sclerosis (MS) to feel more hopeful, happy, and healthy. The main questions it aims to answer are:
- Is a five-week self-directed PP training intervention feasible and acceptable to individuals with newly diagnosed MS?
- Does the completion of a five-week self-directed PP training intervention improve positive affect, emotional function and health-related quality of life (HRQOL) in individuals with newly diagnosed MS?
- Are improvements in positive affect, emotional function and HRQOL maintained after the completion of the intervention?
Participants will be randomized to the intervention or waitlist control group. There will be an intervention phase (weeks 1-5) and an extension phase (weeks 6-10). All participants will complete questionnaires at enrollment, 5 weeks and 10 weeks. They will complete 5 weeks of self-directed PP training exercises, either during the intervention phase (intervention group) or extension phase (waitlist control group) of the study.
Researchers will compare participants in the intervention and waitlist control groups at the end of the intervention phase to see if there are improvements in positive affect, emotional function and HRQOL. For subjects in the intervention group who demonstrate improvement, researchers will determine if the benefit is maintained by comparing positive affect, emotional function and HRQOL at the completion of the intervention and extension phases of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of MS according to the McDonald 2017 diagnostic criteria
- •Onset of disease within the last 2 years
- •Ability to speak, read and write in English
排除标准
- •Moderate or marked cognitive abnormalities identified by the treating neurologist during routine clinical visits that would preclude meaningful participation in the PP exercises
研究组 & 干预措施
Intervention
Subjects randomized to the intervention group will complete questionnaires at enrollment, Week 5 and Week 10. They will also complete 5 weeks of PP exercises, one exercise per week, during the intervention phase (weeks 1-5) of the study.
干预措施: Positive psychology (Behavioral)
Waitlist Control
Subjects randomized to the waitlist control group will complete study questionnaires at enrollment, Week 5 and Week 10. They will also complete 5 weeks of PP exercises, one exercise per week, during the extension phase (weeks 6-10) of the study.
干预措施: Positive psychology (Behavioral)
结局指标
主要结局
Percentage of PP exercises completed by subjects
时间窗: Five weeks
Measured by percentage of PP exercises completed by subjects.
次要结局
- Changes in physical, mental and social health(Five weeks)
- Subject ratings of ease of completion of PP exercises(Five weeks)
- Subject ratings of utility of PP exercises(Five weeks)
- Changes in affect(Five weeks)
- Change in trait optimism(Five weeks)
- Changes in resilience(Five weeks)
研究者
Bonnie Ilene Glanz
Research Associate
Brigham and Women's Hospital